Kornimate/medical-research-clean huggingface dataset:
e7080 in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (nsclc)

Conditions: Non-small-cell Lung Cancer

Summary: the purpose of this study is to determined the maximum tolerated dose (mtd), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of e7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc). 2. locally advanced and/or metastatic non-small cell lung cancer (nsclc) (stage iiib/iv). 3. subjects with at least one measurable tumor lesion by response evaluation criteria in solid tumors (recist). 4. subjects with performance status (ps) 0-1. 5. subjects with adequate organ function. exclusion criteria: 1. subjects who have ever received the following therapy for non-small cell lung cancer (nsclc): 1. chemotherapy 2. biological or immunotherapies 3. surgery for primary focus 4. the radiation therapy for primary focus 2. subjects with the severe complications or disease history. 3. subjects with brain metastasis accompanying clinical symptoms or requiring treatment. 4. subjects with simultaneous or metachronous cancers. 5. subjects who cannot take oral medication. 6. subjects who are using drugs that strongly inhibit or induce cytochrome p450 (cyp) 3a4.

Keywords: cancer lung cancer
coffee roasting and glucose tolerance

Conditions: Oral Glucose Tolerance

Summary: chlorogenic acid (cga) in coffee may lower the postprandial glucose response. cga is destroyed by dark roasting. in a controlled crossover trial, 11 healthy fasted volunteers consumed 300 ml of either light (lir) or dark (dar) roasted coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (ogtt). plasma glukose and insulin, appetite, and plasma and urine metabolic profiles will be analysed. the primary aim is to investigate whether roasting affects the postprandial glucose area under the curve (auc).

epidemiologic evidence suggests that coffee consumption is associated with a lower risk of type 2 diabetes. coffee contains caffeine and several other components that may modulate glucose regulation. the chlorogenic acids (cga) in coffee have been indicated as constituents that may help to normalize the acute glucose response after a carbohydrate challenge. the aim of this study was to investigate whether two coffee beverages that differ in cga content due to different roasting degrees will affect glucose regulation differently. in a controlled crossover trial, 11 healthy fasted volunteers consumed 300 ml of either light roasted (lir) or dark roasted (dar) coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (ogtt). blood samples were drawn at baseline, 30, 60 and 120 min. differences in glucose and insulin responses and insulin sensitivity index (isi) were analyzed. the cga and caffeine contents in the coffees were analyzed using uplc-ms/ms.

Eligibility criteria:
inclusion criteria: body mass index (bmi) of 18.0-30.0 kg/m2 and with no known diseases exclusion criteria: * systemic infections, * psychiatric or metabolic disorders, * known food allergies or intolerances related to the products used in the study (e.g. dairy or gluten), * ongoing or former drug abuse, * high intake of alcohol (defined as a weekly intake of \>7 units for women and \> 14 units for men), * pregnancy or ongoing planning of pregnancy, * vegetarianism or veganism, * participation in other scientific studies during the study period, and * blood donation during - or in the month leading up to - the study period

Keywords: coffee chlorogenic acid insulin appetite metabolomics
study to evaluate the incidence, clinical characteristics and economic burden of dengue in brazilian children

Conditions: Dengue

Summary: the aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in forteleza (brazil).

prospective cohort study. the study period initially planned to be two years, is extended by one year to cover one additional dengue season.

Eligibility criteria:
inclusion criteria: * male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment. * written informed consent (and assent when applicable). * subjects who the investigator believes that they and/or their parent(s)/lar can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc). * subjects who plan to attend one of the study schools for two school years following enrollment. exclusion criteria: * subjects planning to move from the study area during the two school years following enrollment. * child in care. * enrollment in another study that would conflict with the current study.

Keywords: brazil incidence dengue virus dengue dengue infection
enhancing motor learning in children with cerebral palsy using transcranial direct-current stimulation

Conditions: Cerebral Palsy

Summary: the goal of this study is to test the effects of transcranial direct current stimulation (tdcs) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (uscp).


Eligibility criteria:
inclusion criteria: children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. ability to cooperate and follow simple directions. exclusion criteria: * seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tdcs or tms (pacemaker, medication pump, cochlear implant, implanted brain stimulator) * true positive response on the transcranial magnetic stimulation and mri safety screen * current use of medications known to lower the seizure threshold * previous episode of unprovoked neurocardiogenic syncope * indwelling metal or incompatible medical devices * centrally-acting medications including anti-seizure medications * evidence of scalp disease or skin abnormalities * current medical illness unrelated to cp * high motor ability in affected arm (i.e. no asymmetry in scores of hand function) * severe spasticity * lack of asymmetry in hand function * orthopedic surgery in affected arm * botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period * currently receiving intrathecal baclofen * history of broken arm (either arm) 1 year prior to study enrollment
68ga-fapi pet/ct imaging for diagnosis, grading, and efficacy evaluation of myelofibrosis.

Conditions: Primary Myelofibrosis

Summary: to evaluate the diagnostic efficacy of 68ga fapi pet/ct in myelofibrosis and to identify fibrosis grades. to evaluate the diagnostic efficacy of 68ga fapipet/ct imaging in patients with myelofibrosis, compared with conventional ct.

this study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (sensitivity, specificity, positive prediction rate, negative prediction rate) of 68ga fapi pet/ct in myelofibrosis and to identify fibrosis grades.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. cohort 1: patients with suspected or confirmed myelofibrosis; cohort 2: patients with primary/secondary myelofibrosis who were not treated with ruxolitinib. 3. the expected survival time is over 3 months 4. voluntarily sign informed consent. 5. willing and able to follow the research protocol; 6. the subject must be able to lie on the scanning bed for 20 minutes; exclusion criteria: 1. known allergic history to 68ga fapi or its excipients; 2. patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history); 3. those who are not suitable for or unable to complete imaging tests such as pet due to special reasons, including claustrophobia and radiophobia; 4. pregnant and lactating women; 5. workers who are exposed to radiation for a long period of time; 6. serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis; 7. participating in other interventional clinical trials within 1 month before screening; 8. patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers; 9. there are other circumstances that the researcher thinks are not suitable for participating in this study;

Keywords: myelofibrosis positron emission tomography / computed tomography
an extension study of methylnaltrexone bromide (mntx) in participants with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this open-label extension study will evaluate the long-term safety and efficacy of oral mntx in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in study sal-rel-2042 (nct04083651).


Eligibility criteria:
inclusion criteria: * adult participants greater than or equal to (≥)18 years of age on the date the informed consent form (icf) is signed, with the capacity to provide voluntary informed consent. * enrolled in double-blind study sal-rel-2042 (nct04083651) and completed an end of study (eos) visit (day 168) or completed day 56 of the study sal-rel-2042 (nct04083651). * must be able to read, understand, and provide written informed consent on the institutional review board (irb)-approved icf and provide authorization, as appropriate, for local privacy regulations. * willing and able to comply with scheduled visits, the treatment plan, and laboratory tests. * signed an informed consent/health insurance portability and accountability act (hipaa) form. exclusion criteria: * concurrent therapy with any other investigational agent during the study. * current use of a peripherally acting mu-opioid-receptor antagonist. * current evidence of untreated brain metastasis(es). * diarrhea greater than grade 1, based on the national cancer institute common terminology criteria for adverse events version 5.0 (nci-ctcae v5.0). * bowel obstruction. * advanced liver disease. * renal disease. * any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the principal investigator, would make the participant inappropriate for the study.
suprazygomatic maxillary nerve block in cleft palate outcomes

Conditions: Cleft Palate Children

Summary: increased pain after cleft palate surgery is the leading cause of increased hospital length of stay, delayed oral intake, readmission, and respiratory compromise. the goal is to improve all outcomes by identifying the most effective evidenced-based method of intra-operative pain control.

cleft palate repair is associated with significant perioperative pain that may require increased depth of anesthesia intraoperatively and can interfere with oral intake and accentuate breathing difficulties postoperatively, resulting in increased length of hospital stay. optimizing pain control in the perioperative period is essential to best practice for cleft palate repair. infiltration of the palate with local anesthetic has long been the established mechanism for pain control to minimize intraoperative anesthetic requirement and postoperative opioid use. suprazygomatic maxillary nerve block (smb) administered immediately prior to cleft palate repair by anesthesiologists with fellowship training in regional anesthesia is an emerging technique for local anesthetic infiltration. the latter technique is thought to provide superior pain control due to its precise and targeted action on the nerves that innervate the palate, and because it is felt that duration of action may also be prolonged due to specific infiltration around these nerves as opposed to generalized infiltration in the palatal soft tissues. the goal of our study is to evaluate outcomes following the two routes for anesthetic infiltration during cleft palate repair. if either technique is found to be more effective or of greater duration, this can have direct impact in decreasing the need for perioperative opioid use, decreasing hospital length of stay, and less potential for airway suppression from excessive use of postoperative analgesics.

Eligibility criteria:
inclusion criteria: * all patients undergoing primary cleft palate repair at ann \& robert h. lurie children's hospital of chicago during the enrollment period. the typical child at the time of cleft palate repair is age 11 to 12 months. exclusion criteria: * children with a known allergy to local anesthesia (i.e., ropivacaine or bupivacaine). * children with prior surgical repair of the palate.

Keywords: nerve block
electronic and lab pre-screening of new rheumatology patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Inflammatory Arthritis

Summary: by forming the foundation of a delivery system that integrates primary care (pc) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. importantly, it strives to fill an unmet need, the rapid evaluation by primary care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (ra) with tight control. given the call for improved quality, value, and demonstration of results\[1\], this initiative uses the tenets of national center for quality assurance's patient centered specialty program\[1\] (pcsp) and it successfully masters and streamlines coordination of care.


Eligibility criteria:
inclusion criteria: * first ever referral to a rheumatologist. exclusion criteria: -
early evaluation of the beacon aqueous microshunt in patients refractory to drug therapy in the european union

Conditions: Glaucoma, Open-Angle

Summary: this is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the beacon aqueous microshunt. a total of 65 subjects will be enrolled at five centers. the primary endpoint will be assessed at 12 month follow-up.


Eligibility criteria:
inclusion criteria: 1. age 22 years and older. 2. diagnosed with mild, moderate or severe open-angle glaucoma (oag). 3. best corrected vision acuity 20/25 or worse in the study eye. 4. inadequate medical control of iop, or target iop not reached with intraocular pressure in the study eye greater than or equal to 20 mmhg. 5. at least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye. 6. adequate space in the anterior chamber of the study eye sufficient to support implant with the bam, defined as two contiguous clock hours of scleral spur visualization via gonioscopy, without compression, in the superior 180 degrees of the anterior angle. 7. any iop-lowering medications should be stabilized at least 30 days prior to baseline measurements. 8. able and willing to comply with protocol requirements. 9. able to understand and sign the informed consent form. exclusion criteria: 1. active neovascular glaucoma in the study eye. 2. pigmentary glaucoma in the study eye. 3. pseudoexfoliative glaucoma in the study eye. 4. any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the eye. 5. corneal conditions in the study eye that may inhibit normal incisional healing (e.g. fuch's dystrophy) or impair visualization of the implant inside the anterior chamber. 6. anticipated need for ocular surgery within one year in the study eye. 7. contact lens use in the study eye. 8. clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. for purposes of this study, clinically significant is considered any such condition requiring prescription therapy. 9. other clinical conditions: 1. poorly controlled diabetes (type i or type ii) as determined by hba1c \>8. 2. cancer requiring treatment during the duration of the study. 3. any drugs (e.g.: immunosuppressive drugs) or co- morbidity that might inhibit wound healing. 10. participation in any other clinical trial during participation in this trial. 11. life expectancy \<1 year. 12. clinically significant macular degeneration in the study eye. 13. patients who have undergone surgery in the trial eye within the last 6 months. 14. planned combined cataract surgery. if both eyes of a prospective trial participant are eligible, the eye with the highest intraocular pressure will be selected for implant.
assessment of chilbains occuring during covid-19 infection

Conditions: Skin Manifestations; COVID; Chilblains

Summary: some patients infected by covid-19 develop skin manifestations. these manifestations are still not well known and there pathophysiology remain unclear. among them, acral manifestation resembling to chilblains appears frequent and quite specific. the aim of this project is to better characterize the cutaneous manifestations occurring during covid-19 infection with a special focus on chilblains. these acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. this study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the chu of nice in covid-19 patients.


Eligibility criteria:
inclusion criteria: * all patients with proven covid infection (using pcr, serum antibody or lung tdm) and presenting at least one cutaneous lesions that occurred during the infection.
intravesical injection of botox for treating therapy refractory overactive bladder in females

Conditions: Overactive Bladder Syndrome

Summary: the neurotoxin botox (botulinum neurotoxin type a) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. our data suggests a longer during efficacy than known from the use in striated muscle. the aim of our study is to analyze short- and longterm efficacy after botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.


Eligibility criteria:
inclusion criteria: * intravesical treatment with botox at our clinic

Keywords: botulinum neurotoxin type a bont/a botox overactive bladder syndrome
post-natal depression and chronic stress

Conditions: Depression, Postpartum

Summary: the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. the pnd appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies. this study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression

the prevalence of postnatal depression is high in civilian settings (20%). in mechanistic terms, the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. the post natal depression appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies. * on the one hand, the repetition of stressors during pregnancy corresponds to a natural chronic stress model of several months and thus allows to study the biological cost of responses to repeated stresses, and the adaptive mechanisms leading to from functional drift to psychic dysfunction. * on the other hand, isolated vulnerability factors characterize a mirroring psychological profile of a mindfulness type of functioning. mindfulness or full consciousness has been described as a state of consciousness which results from intentionally, at the present moment, without judging the experience that unfolds moment by moment. this psychological resource has been associated with resilient or even resilient psychic functioning. this study aim to follow a cohort of pregnant women from the first trimester of pregnancies to 2 months after the delivery to determine the predictive psychobiological factors of the emergence of postnatal depression

Eligibility criteria:
inclusion criteria: * physiological pregnancy * follow-up of pregnancy in a participating maternity * female over 18 years * affiliated to a social security scheme exclusion criteria: * multiple pregnancy * psychiatric, neurological, or endocrine or autoimmune diseases * hormonal or psychotropic treatments

Keywords: postnatal depression stress mindfulness allostatic load
risk of bleeding and anticoagulation in atrial fibrillation: what predictive criterion used?

Conditions: Atrial Fibrillation; Gerontology

Summary: atrial fibrillation (af) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. it is a public health problem with 600,000 to 1 million people involved in france which 2/3 are aged over 75 years. a fa untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. the anticoagulant standard treatment helps prevent the occurrence of this complication. however, oral anticoagulation also exposes patients to an increased risk of bleeding. the bleeding risk can be assessed using scales: several being proposed (hemorr2hages, has-bled, atria and scores shireman and charlson ...). moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social. thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.


Eligibility criteria:
inclusion criteria: * hospitalisation in geriatric unit * atrial fibrillation treated by anticoagulant treatment (avk or oral anticoagulation) * signed inform consent exclusion criteria: * estimated lifetime less than 6 months * under guardianship or curatorship * without support person

Keywords: anticoagulant